Cleared Traditional

K113173 - NANOVIS SPINAL SYSTEM

K113173 is an FDA 510(k) clearance for NANOVIS SPINAL SYSTEM, manufactured by Nanovis, LLC. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K113173 · Nanovis, LLC · Orthopedic device
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Jan 2012
Decision
84d
Days
Class 2
Risk

K113173 is an FDA 510(k) clearance for the NANOVIS SPINAL SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Nanovis, LLC (Chesterland, US). The FDA issued a Cleared decision on January 19, 2012 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nanovis, LLC devices

FDA 510(k) Submission Details - K113173

510(k) Number K113173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2011
Decision Date January 19, 2012
Days to Decision 84 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 122d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NKB Device Classification - Class 2, Special Controls

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - NKB Thoracolumbosacral Pedicle Screw System

All 731
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K113173.
DEPUY PULSE THORACOLUMBAR SCREW SYSTEM
K113396 · Medos International SARL · Feb 2012
CORAL SPINAL SYSTEM
K120047 · Theken Spine, LLC · Feb 2012
XENON(TM) PEDICLE SCREW SYSTEM
K111634 · Alphatec Spine, Inc. · Jan 2012
FOCUS MIS SYSTEM
K112643 · L & K Biomed Co., Ltd. · Jan 2012
SYNTHES MIRS
K113044 · Synthes Spine · Dec 2011
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
K113434 · Lanx, Inc. · Dec 2011